This invention relates to the field of devices or appliances used to relieve or mitigate the problems associated with human urinary incontinence. More specifically, the present invention relates to a removable external closure for the human female urethra.
Urinary incontinence, due to disease, injury, or other causes, is a troublesome problem for many individuals. Surgical intervention is often required to treat severe cases of incontinence, but in those cases where the patient suffers from only a partial loss of bladder control, or where the patient is a poor candidate for surgery or does not desire to undergo surgery, nonsurgical treatment is called for. Such nonsurgical approaches are particularly appropriate for female patients who suffer from the partial, sporadic loss of bladder control sometimes referred to as "stress incontinence" or "urge incontinence". Such stress or urge incontinence, in fact, is the most common cause of involuntary urine loss in adult women.
Nonsurgical management of female urinary incontinence includes non-therapeutic management, wherein the patient wears an appliance or device proximate the urethral orifice ("meatus") that collects or captures urinary discharge. Such devices fall generally into two categories: (1) urine collection devices, and (2) absorbent pads.
Urine collection devices typically comprise a receiving orifice or receptacle for capturing urine flowing from the urethra; retention means, associated with the receptacle or orifice, for holding the receptacle or orifice in the proximity of the urethral meatus; and means for directing urine from the receptacle or orifice to a reservoir or a container or the like for disposal. Devices of this general description are disclosed in the following U.S. Pat. Nos.: 3,512,185--Ellis; 3,661,155--Lindan; 4,412,511--Steer et al.; 4,457,314--Knowles; 4,484,917--Blackmon; 4,690,677--Erb; 4,822,347--MacDougall; and 4,846,819--Welch. A variation on the urinary collection device theme is the "female external catheter", disclosed in U.S. Pat. No. 4,563,183--Barrodale et al., which includes a catheter tube having one end inserted into the urethra. In many of these devices, the retention means are configured so as to be inserted into the interlabial space, being retained therein by the anatomical structure of the external female genitalia. The Blackmon and MacDougall devices also use an adhesive to assist in retention.
The category of absorbent pads includes a wide variety of devices which generally comprise a body of absorbent material configured so as to be insertable into the interlabial space, and retained therein by the anatomical structure of the external female genitalia. Such devices typically resemble (and, indeed, can function as) catamenial sanitary napkins. The following U.S. Patents disclose devices that may generally be considered within this category: U.S. Pat. Nos. 3,983,873--Hirschman; 4,595,392--Johnson et al.; 4,627,848--Lassen et al.; 4,673,403--Lassen et al.; 4,743,245--Lassen et al.; 4,804,380--Lassen et al.; and 4,846,824--Lassen et al. A sanitary napkin that is configured for interlabial retention, and that could be used to capture and absorb urine flow, is disclosed in British Patent No. 754,481.
While the above-described devices are useful in certain applications, they are subject to a number of disadvantages. For example, the urine collection devices require the user to wear a reservoir or container that may be prone to overflow or spillage Also, such devices are better suited to users who suffer from chronic or severe loss of bladder function, rather than those who suffer only from stress or urge incontinence. The absorbent pads tend to be bulky, and may be uncomfortable for some users, especially when wet.
Use of the prior art devices described above is based upon the assumption that the flow of urine out of the urethra cannot or should not be stopped. This assumption may not be true in many cases of stress or urge incontinence. In such cases, external occlusion of the urethral meatus may provide an adequate degree of continence for many patients, but this approach has been overlooked by the prior art.
There is, therefore, a need for a device that provides for the effective management of female stress or urge incontinence by means of the external occlusion of the urethral meatus; that is easy to use and comfortable to wear; and that provides for secure retention with good sealing qualities.